The Fact About Abbreviated New Drug Application (ANDA) That No One Is Suggesting
It doesn't require preclinical and medical trials but have to show bioequivalence by way of bioavailability and bioequivalence studies. The ANDA contents and evaluate approach are outlined according to the Typical Technical Document structure in 5 quality, nonclinical, and scientific modules.For that reason, Whilst FDA's evaluate of Stage 1 submiss